Asia’s growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India’s GDP figures progressed from 7% to 9% over the same period. These countries’ medical device markets are growing at similarly high rates as their populations demand better healthcare to match their new living standards. On the other hand, Japan and Korea, with slower GDP growth (2% in Japan and 5% in Korea in 2006), are also attractive, mature markets for medical devices. This article discusses recent medical device regulatory developments in these major markets.
Reacting to product scandals and corruption cases, China’s State Food and Drug Administration (SFDA) has cracked down on the medical market, announcing new laws and drafting new regulations. Determined to address growing concerns about quality control and adverse events, SFDA has issued regulations on standardizing product registration, medical device industrial standards and inspection of medical devices. In addition, the agency has issued prohibitive rules for personnel involved in medical device registration.
Recently, SFDA implemented the revised Standard Registration Procedures for Domestic Class III Medical Devices and Imported Medical Devices (interim). The procedures detail the registration process, describing three main phases. Each phase has specific time limits.
The first phase is application acceptance, handled by SFDA’s Administrative Service Center. The center checks the application’s completeness and also notifies applicants if forms are incomplete.
The second phase is technical evaluation, supervised by the agency’s Center for Medical Device Evaluation. Technical evaluation consists of checking a medical device’s safety and efficacy.
The third phase is administrative approval, handled by SFDA itself. The agency verifies the application and the technical evaluation, ensuring everything has been administered properly. After complete review and the official final decision, SFDA issues approval of the medical device.
To improve quality control and manage adverse events, SFDA has also proposed regulations to intensify control over the safety of medical products. These regulations, if approved, would make it mandatory for manufacturers to recall defective or unsafe medical devices. Manufacturers failing to comply would be fined by the government. If there are serious adverse events, the government will also revoke production licenses and may press criminal charges.
In addition, China has released provisions on inspecting imported medical devices. These provisions outline details on monitoring imported medical devices, which depend upon the classification given to the importer. For example, importers that have maintained a good quality history will be classified as Type 1 and subject to fewer on-site inspections. Importers that are less-qualified and have less-impressive track records will be classified as Type 2 or 3 and subject to more on-site inspections of their shipments.
To address issues of corruption, SFDA has issued prohibitive rules for personnel involved in food and drug supervision. These rules prohibit such activities as direct or indirect ownership of stocks in medical-related companies, collecting lecture fees and receiving expensive gifts. Depending upon the infraction, violators may be internally reprimanded, face disciplinary action or be turned over to judicial authorities.
Through these various new regulations, China has increased its supervision and management of the medical market to ensure better quality.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has issued various initiatives to quicken its medical device approval process. One of its earlier programs included the “Harmonization by Doing” (HBD) initiative. The HBD program was launched in December 2003. Its two meetings to date were held in December 2005 and January 2007.
HBD was initially launched to focus on regulatory convergence between the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare (MHLW) for cardiovascular-oriented medical device technology (specifically, drug-eluting stents). By developing common protocols for investigational clinical studies, HBD would allow parallel medical device application development, submission and review by both FDA and MHLW. Harmonized clinical trial data could be used in the US and Japan, and would allow shorter approval times. Though this initiative is currently limited to cardiovascular products, it may be expanded in the future to include other fields such as orthopedics.
FDA has suggested that HBD could be applied not only to premarket activities but also to such postmarket activities as clinical trials, data collection and patient registries.
PMDA has added new categories of consultations it offers applicants to help navigate the regulatory process. Some of these are for general, preliminary inquiries, while others are for more-specific issues such as local clinical trials. Prices for these sessions vary depending upon the nature and timing of the consultation.
Currently, two types of consultative sessions cater specifically to clinical trial inquiries. PMDA proposes adding 11 more consultation categories. One new category is for determining whether existing clinical trials outside Japan should be sufficient for registration or if local clinical trials will be required. For example, such consultations would look at existing foreign clinical data in conjunction with preclinical data to assess their sufficiency. Many of these new category topics are very specific. Government consultation fees can range from $5,000 to over $40,000.
PMDA is adding only one additional category for the preliminary, general consultative sessions. This is for Good Manufacturing Practice (GMP) and Quality Management System (QMS) inquiries. These preliminary consultations usually cost around $200.
Other future plans to improve medical device approval times include increasing the number of medical device reviewers by 30% by 2009. In addition, there are plans to form a task force to improve medical device technological upgrade reviews and clarify raw material data requirements. This task force would also specify whether a product change requires a partial change application or a simple notification to PMDA. Other plans include providing the US medical device industry with more opportunities to discuss reimbursement policies and pricing procedures.
By implementing these changes, Japan hopes to stimulate the medical device market, streamline product registration and decrease regulatory approval processing times.
One of the biggest recent developments in Korea medical device regulations that will surely affect the market, was the free trade agreement (FTA) with the US in June 2007, which followed 10 months of lengthy discussions and meetings. Among the various industries addressed was the medical device market.
Provisions include a commitment to ensure transparency in Korea’s pricing and reimbursement system, and the creation of an independent review mechanism for pricing and reimbursement decisions.
The FTA also includes pledges to ensure ethical business practices and increase protection of intellectual property rights, and new rules on civil, criminal and customs enforcement. Finally, the agreement contains provisions on establishing a patent linkage system to ensure adequate enforcement of intellectual property rights.
To better cover medical devices and speed harmonization, the Korea Food and Drug Administration (KFDA) passed a new piece of Korea medical device regulation in 2003, Medical Device Act. Full enforcement of the act, including new regulations on Korean GMP (KGMP) compliance and adverse events, went into effect in 2007.
When registering a medical device in Korea, an applicant must demonstrate KGMP compliance. Previously, under the Pharmaceutical Affairs Act, foreign manufacturers could demonstrate KGMP compliance with an ISO 13485:2003 or US FDA QSR certification. KFDA audits applied only to Korean manufacturers. However, the new KGMP rules under the Medical Device Act now state that importers of medical devices will be either subject to local testing or required to provide essential test reports. This new Korea medical device regulationis part of the Import and Quality Management Systems (locally called Good Import Practices, or GIP).
KFDA currently has a list of essential tests required to ensure the quality of imported medical devices, ranging from sterility tests to grounding resistance tests, depending upon the product. Importers will need to determine whether foreign manufacturers already have the appropriate test reports or if local testing is necessary. Companies failing to comply will be banned from selling devices.
The Medical Device Act also introduces new postmarketing surveillance requirements with adverse event reporting, safety alerts and medical device tracking.
India has focused primarily on drug regulations and establishing a drug regulatory framework. Although this infrastructure has been in place for many decades, India has just begun to address medical devices as a separate regulatory category. Generally, medical device regulation consists of officially classifying certain devices as “drugs” and applying drug laws to them. Since 1 March 2006, 10 medical devices have been classified as drugs and added to this list, but the government has begun developing specialized regulations for these devices.
The Central Drug Standards Control Organization (CDSCO), India’s chief drug regulator, established a subcommittee to determine licensing rules for these 10 medical devices in December 2006. Recently, this subcommittee was given the responsibility of establishing standards for manufacturing, technical staff qualification and testing processes for each device. The only Indian regulations adapted for these devices thus far are the actual registration procedures.
India’s Department of Science and Technology (DST) has also prepared draft legislation on a regulatory framework for all medical devices. This framework would provide the initial steps in establishing a separate system for medical device registration. For example, validation would be required before any medical device is certified for use in the country.
Because India depends heavily upon imported medical devices, the DST hopes that this new regulatory framework will encourage international companies to increase exports and also to manufacture in India. High-quality manufacturers and lower labor costs encourage production there.
The central government has recently drafted legislation to ensure quality control of vital lifesaving medical devices such as endoscopes and pacemakers. Prepared by the Sree Chitra Tirunal Institute for Medical Sciences and Technology, the draft has been forwarded to the Ministry of Health and Family Welfare. The bill proposes regulatory guidelines to test and certify medical devices introduced into India. Imported devices may also be required to be certified based upon these regulatory guidelines.
Asia’s medical device regulatory requirements are changing and, for the most part, becoming more stringent. China’s device regulatory system is reeling from corruption scandals and must improve its quality standards. India has just started to implement a medical device regulatory framework. Both these countries have some distance to go before their systems are fully functional. The well-developed systems in both Japan and Korea medical device regulations are working toward greater transparency and more-efficient product approvals. Under pressure from the domestic front as well as the global medical industry, Asian governmental and health authorities will continue to adjust or revamp their systems.
Ames Gross is the President and founder of Pacific Bridge Medical. He is recognized nationally and internationally as a leader in Asian medical markets.
Momoko Hirose is Senior Associate at Pacific Bridge Medical, working on research, writing and consulting projects.